A disposable sterile breakable vial includes a handle section and a vial section which are completely separable in response to a manually applied separation force. The vial section includes a sterile void dimensioned to contain a unit dose of a sterile therapeutic topical agent. An elongated member comprises a proximal portion supported by the handle section and a distal portion provided with a sterile applicator element, such as a brush. At least the applicator element is completely enclosed within the vial section with the applicator element immersed within the therapeutic topical agent. A hermetic seal between the handle and vial sections maintains sterility of at least the vial section prior to handle and vial section separation. Complete separation of the handle section and the vial section exposes the elongated member and the applicator element for topical application of the therapeutic agent saturating the applicator element.
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1. A method of applying a therapeutic topical agent to a body part, wherein the method comprises:
applying a force to a handle section and a vial section of a breakable vial, wherein:
the breakable vial is completely separable into the handle section and the vial section in response to a manually applied separation force;
the vial section comprises a sterile void containing a unit dose of a therapeutic topical agent, wherein the therapeutic topical agent comprises a prostaglandin analog;
the handle section comprises a sterile applicator comprising a handle, a shaft, and a brush, the handle section supporting the handle, and at least a portion of the shaft and the brush being completely enclosed within the breakable vial with the brush extending into the sterile void and immersed in the therapeutic topical agent, wherein the brush has a generally tapered shape comprising bristles of differing length that serves to trap the therapeutic topical agent using capillary action and comprises multiple bristles molded thereto; and
a hermetic seal between the vial section and the handle section that maintains sterility of the void, the therapeutic topical agent, the shaft, and the brush prior to separation of the handle section and vial section, wherein complete separation of the handle section and the vial section exposes the sterile shaft and the brush for topical application of the therapeutic agent saturating the brush;
separating the handle section from the vial section; and,
applying the therapeutic topical agent to the body part.
6. The method of
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This application is a continuation of U.S. patent application Ser. No. 13/398,231, filed Feb. 16, 2012, which claims the benefit pursuant to 35 U.S.C. §119(e) to U.S. Provisional Patent Application Ser. Nos. 61/444,308, filed Feb. 18, 2011; 61/539,177, filed Sep. 26, 2011; and 61/568,254, filed Dec. 8, 2011, each of which are incorporated herein by reference in its entirety.
Embodiments of the disclosure are directed to unit dose vials with integrated applicators for topical application of a liquid contained in the vials. Embodiments of the disclosure are directed to unit dose vials with integrated applicators that maintain sterility of a liquid contained therein for topical application of the liquid to specified areas of the body. Embodiments of the disclosure are directed to a unit dose vial and applicator with an enclosed brush system for topical application of a therapeutic agent to skin at the eyelid, eyebrows, and other areas of the body.
In accordance with various embodiments, a disposable sterile apparatus for topical application of a sterile therapeutic agent includes a breakable vial comprising a handle section and a vial section. The breakable vial is completely separable into the handle section and the vial section in response to a manually applied separation force. The vial section includes a sterile void dimensioned to contain a unit dose of a sterile therapeutic topical agent. An elongated member comprises a proximal portion supported by the handle section and a distal portion provided with a sterile applicator element. At least the applicator element is completely enclosed within the vial section with the applicator element immersed within the therapeutic topical agent. A hermetic seal is provided between the handle and vial sections. The hermetic seal maintains sterility of at least the vial section prior to handle and vial section separation. Complete separation of the handle section and the vial section exposes the elongated member and the applicator element for topical application of the therapeutic agent saturating the applicator element.
According to other embodiments, a disposable, unit-dose sterile apparatus for topical application of a therapeutic agent includes a breakable vial comprising a handle section and a vial section. The breakable vial is completely separable into the handle section and the vial section in response to a manually applied separation force. The vial section includes a sterile void dimensioned to contain a unit dose of a sterile therapeutic topical agent. A sterile applicator includes a handle, a shaft, and a brush. The handle section supports the applicator handle, and the brush and at least a portion of the shaft are completely enclosed within the breakable vial with the brush extending into the sterile void and immersed in the therapeutic topical agent. A hermetic seal between the vial section and the handle section maintains sterility of the void, the therapeutic topical agent, the shaft portion, and the brush prior to handle and vial separation. Complete separation of the handle section and the vial section exposes the sterile shaft portion and the brush for topical application of the therapeutic agent saturating the brush.
In some embodiments, the breakable vial, the applicator, and the brush are formed from disparate materials. In other embodiments, at least two of the breakable vial, applicator, and brush are formed from the same material. In further embodiments, the breakable vial, applicator, and brush are formed from the same material. According to various embodiments, the therapeutic topical agent comprises a property of a tough extractable profile, and the breakable vial, applicator, and brush are formed from the same material, such as low density polyethylene.
Various sterile and therapeutic topical agents can be contained in the breakable vial, such as a prostaglandin analog, a prostamide, prostaglandin C-1 ethyl amides, bimatoprost including its prodrugs, latanoprost, travaprost, and a pharmacological agent such as a wound healing agent. In some embodiments, the therapeutic topical agent contained in the breakable vial may be in a formulation such as the commercially available hair growth product LATISSE®, which can be applied to the skin along an eyelid or eyebrow using the applicator brush integrated in the handle section of the breakable vial.
According to further embodiments, various methods involve applying a force to each of a first section and a second section of a disposable breakable vial. The first section of the breakable vial includes a vial having a sterile void dimensioned to contain a unit dose of a sterile therapeutic topical agent. The second section of the breakable vial includes a handle, an elongated sterile applicator supported by the handle, and a brush provided at a distal end of the applicator extending into the sterile void of the vial and immersed in the therapeutic topical agent. Various methods further involve facilitating complete separation of the first and second sections preferentially along a separation feature in response to the force applied to each of the first and second sections, wherein complete separation of the first and section sections breaks a hermetic seal between the vial and the handle and brush, and exposes the handle and brush for topical application of the therapeutic agent saturating the brush. Some methods involve applying a therapeutic topical hair growth agent to skin along an eyelid or eyebrow using the exposed handle and brush.
Some embodiments of the present invention include the following:
These and other features can be understood in view of the following detailed discussion and the accompanying drawings.
Embodiments of the disclosure are directed to breakable unit dose vials which fully enclose a therapeutic agent and an applicator for topically applying the therapeutic agent to the skin, such as the eyelids or eyelid margin or the surface of the skin such as the scalp or skin directly under the eyebrows. The breakable vial is preferably constructed to break easily into two-pieces by a user; a handle section and a vial section. An exterior surface of the handle section is shaped for easy grasping and manipulation by the user. An interior portion of the handle section provides support for the applicator, which includes an elongated member and an applicator element, such as a brush, sponge, pad, or comb, for example, provided at the distal end of the elongated member.
Until broken into two-pieces by the user, the applicator element is immersed in the therapeutic agent contained within the vial section, with the vial section sealed to maintain sterility of the therapeutic agent and at least the applicator element. When a user breaks or opens the vial, the applicator element and handle are available. Because the applicator element is immersed in the therapeutic agent prior to separating the handle and vial sections of the breakable vial, the wetted applicator element is made available for immediate use, such as for applying the therapeutic agent on the brush to skin along the eyelids or eyebrows. Each breakable vial preferably contains a unit dose of the therapeutic agent, contains no preservative, and is disposed of after application. A unit dose is generally understood as the amount of medication administered to a patient in a single dose. The breakable vials may come in the form of a card of vials, where multiple vials are connected and individual vials may be easily detached from the card of vials. Each breakable vial of a card of vials preferably contains a single dose of the therapeutic agent for application.
The therapeutic agent may be any therapeutic to be applied topically and is generally non-preserved in unit dose form. Some therapeutic agents include agents such as bimatoprost, latanopost, travaprost or other prostaglandin analog such as prostaglandin C-1 ethyl amides, cyclosporines such as cyclosporine A; topical antibiotics such as bacitracin, neomycin, neosporin, mupirocin and polymyxin B; and topical anti-inflammatories such corticosteroids, NSAIDS and DMARDS The therapeutic agent may be in a formulation such as a solution, emulsion or dispersion or the commercially available hair growth product LATISSE® which is a 0.03% w/v bimatoprost solution and may be non-preserved. The vials may also contain an engraving or other indicia of source or the product name, such as LATISSE®.
According to some embodiments, an applicator brush is enclosed inside the breakable vial and has a handle affixed to the brush for easy handling by the user for application of one of the therapeutic agents listed above to skin along an eyelid or eyebrow. The brush typically includes a multitude of bristles which may include a particular coating designed to release dilute prostamide solutions to the surface of the skin along the eyelid or eyebrow.
Referring to
The handle section 122 of the breakable vial 100 supports or otherwise incorporates a handle 124 of an applicator 120. The applicator handle 124 may include a shoulder 126 which, in some embodiments, enhances handling of the handle section 122 during manufacturing. Accordingly, the shoulder 126 may be included or excluded depending on the manner in which the breakable vial 100 is manufactured. The applicator 120 further includes a shaft 130, and an applicator element 132 is provided at a distal end of the shaft 130. The applicator element 132 is typically constructed as a separate component and incorporated at the distal end of the shaft 130 during manufacturing of the breakable vial 100.
In the embodiment shown in
According to some embodiments, the material used to fabricate the applicator 120 and applicator element 132 is different than that used to fabricate the vial 104. Suitable materials include polyethylene or polypropylene, for example. In other embodiments, the material used to fabricate the applicator 120 and applicator element 132 is the same as that used to fabricate the vial 104. Use of the same material in such embodiments is particularly advantageous when the therapeutic agent 106 contained within the vial 104 has a tough extractable profile. Solutions having a tough extractable profile have the property of attracting nearby material and debris, which can be trapped within the solution and then transferred into the vial 104. Using disparate materials for the applicator 120, applicator element 132, and vial 104 exacerbates this undesirable property, whereas use the same or similar materials for these component reduces or eliminates the adverse impact of this property. In one embodiment, the applicator 120, applicator element 132, and vial 104 are fabricated from low density polyethylene (LDPE), respectively.
The vial section 102 incorporates a vial 104 defining a void dimensioned to contain a prescribed volume of a liquid 106. The vial 104 illustrated in
As is shown in
The volume of the liquid 106 contained within the vial 104 preferably defines a unit dose of a therapeutic topical agent, and the breakable vial 100 is preferably manufactured to be a disposable article. The volume of liquid 106 defining a unit dose typically varies in accordance with the type of therapeutic topical agent contained within the vial 104. Examples of useful therapeutic topical agents dispersed within the liquid 106 that can be contained within the breakable vial 100 include a prostaglandin analog such as a prostamide, prostaglandin C-1 ethyl amides, bimatoprost, latanopost, or travaprost, and a variety of pharmacological agents, such as a wound healing agent or topical antibiotic, anti-inflammatory or antifungal. The volume of the liquid 106 contained within the vial 104 typically ranges from about 0.03 mL to about 0.8 mL. In some embodiments, the vial 104 can be dimensioned to contain a very small volume of the liquid 106, such as about 0.01 mL or 0.02 mL, for example.
According to some embodiments, the separation feature 129 provided between the handle and vial sections 122 and 102 comprises a sealing material, such as a resin, which forms a liquid-tight seal between the handle and vial sections 122 and 102. In other embodiments, the separation feature 129 can define a thinned circumferential section of material (e.g., a thin web of polymeric material) that is used to form the handle and vial sections 122 and 102 during manufacturing, such as by a molding technique. In some embodiments, the liquid-tight seal provided by the separation feature 129 defines an airtight seal, such as a hermetic seal. The need for a liquid-tight seal or a hermetic seal depends largely on the composition of the fluid 107 contained within the vial 104 and the need (or lack thereof) for sterility.
In accordance with various embodiments, the breakable vial 100 is constructed as a disposable sterile article configured to facilitate topical application of a therapeutic agent to a specified portion of a user's body such as the surface of the skin, eyelid, eyelid margin, mucous membrane, surface of the eye, finger nails and toe nails, wound repair and scar reduction. According to such embodiments, the disposable sterile article includes a breakable vial 100 comprising a sterile void or vial 104 dimensioned to contain a unit dose of a sterile therapeutic topical agent. A sterile applicator 120 is completely enclosed within the breakable vial 100 and preferably includes a handle section 120 that supports a brush section 132, for example. At least the brush section 132 of the sterile applicator 120 extends into the sterile void of the vial 104 and is immersed in the therapeutic topical agent. A hermetic seal 129 is provided between the vial 104 and the handle section 122 which maintains sterility of the void, the therapeutic topical agent, and the portion of the applicator 120 extending into the vial 104. The breakable vial 100 is capable of complete separation into first and second sections in response to a manually applied force which exposes the sterile applicator 120 for topical application of the therapeutic agent 106.
According to some embodiments, the therapeutic agent is one that promotes eyelash growth (e.g., LATISSE®), the volume of the vial 104 is sufficient to contain a unit dose of the agent without a preservative, and the applicator 120 includes an integrated brush applicator 132 configured to transfer the unit dose of the agent from the vial 104 to the user's skin along the eyelash. According to other embodiments, the therapeutic agent is one that promotes wound healing, and the volume of the vial 104 is sufficient to contain a unit dose of the wound healing agent. In the context of wound healing agents, a unit dose may be defined as a dose sufficient to cover and “average” size wound, for example. It is noted that the volume of a particular therapeutic agent constituting a “unit dose” will typically differ in accordance with the particular agent's composition and effectiveness, and the body surface to be treated. It is further noted that the volume of a particular therapeutic agent constituting a “unit dose” can differ based on the amount of coverage defining the region of treatment.
A process for fabricating a unit dose breakable vial 100 having an integrated brush applicator in accordance with various embodiments is illustrated in
According to some embodiments, and with reference to
According to some embodiments, the unit dose breakable vial 100 is fabricated using a sterile blow-fill-seal (BFS) manufacturing technique. A BFS manufacturing process typically involves aseptic fabrication of a vessel which is formed, filled, and sealed in a continuous automated process within a sterile enclosed region within the fabrication machinery. Reference is made to
In a separate process, the vial section 102 is formed using a pharmaceutical-grade plastic resin (e.g., polyethylene or polypropylene) typically using a vertical heat extrusion process. The extruded vial section 102 is placed within a two-part mold, and an extraneous top portion of the vial section 102 is cut and removed. A needle mandrel is moved into position relative to the mold and used to inflate the plastic resin to form the void defining the neck 108 and vial 104 of the vial section 102. A filling mandrel is then moved into position relative to the opening of the neck 108 of the vial section 102. A predetermined volume of liquid 106, such as a liquid comprising a therapeutic topical agent, is transferred into the vial 104.
After completion of the liquid filling process, a gripper system 210, depicted in
It is understood that the shape, size, and dimensions of the handle and vial sections 122 and 102 of the breakable vial 100 can differ from the embodiments illustrated in the Figures. For example, the breakable vial 100 can incorporate curved portions, surface features, and indicia or engravings (e.g., “LATISSE®”) that provide for enhanced aesthetics, ergonomics, and product identification.
The various embodiments disclosed herein are generally described in the context of unit dose breakable vials containing sterile fluidic therapeutic agents. It is understood, however, that embodiments of the disclosure have applicability in other contexts, such as for containing fluids other than those comprising therapeutic agents or fluids not requiring sterility. Accordingly, it is to be understood that even though numerous characteristics of various embodiments have been set forth in the foregoing description, together with details of the structure and function of various embodiments, this detailed description is illustrative only, and changes may be made in detail, especially in matters of structure and arrangements of parts illustrated by the various embodiments to the full extent indicated by the broad general meaning of the terms in which the appended claims are expressed.
Slokovic, Lorens F., Gremel, Julie L.
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May 17 2012 | SLOKOVIC, LORENS F | Allergan, Inc | ASSIGNMENT OF ASSIGNORS INTEREST SEE DOCUMENT FOR DETAILS | 033132 | /0268 | |
May 17 2012 | GREMEL, JULIE L | Allergan, Inc | ASSIGNMENT OF ASSIGNORS INTEREST SEE DOCUMENT FOR DETAILS | 033132 | /0268 | |
Jun 17 2014 | Allergan, Inc. | (assignment on the face of the patent) | / |
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